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Efficacy and Safety of LBSA0103 Versus Hyruan Plus Injection in Patients With Knee Osteoarthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01510535
First Posted: January 16, 2012
Last Update Posted: January 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
LG Life Sciences
  Purpose
The purpose of this study is to compare efficacy and safety of intra-articular LBSA0103 once versus intra-articular hyaluronic acid injections (Hyruan Plus Injection) once weekly for 3 weeks in the treatment of patients with osteoarthritis of the knee.

Condition Intervention Phase
Osteoarthritis of the Knee Drug: Placebo Drug: Hyruan Plus Drug: LBSA0103 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Double-blind, Active-controlled, Parallel-group, Randomized, Multi-center Study to Compare Efficacy and Safety of LBSA0103 Once Versus Hyruan Plus Injection Once Weekly for 3weeks in the Treatment of Patients With Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Weight-bearing pain [ Time Frame: 12 weeks after the last injection ]
    using 100mm-VAS


Secondary Outcome Measures:
  • Weight-bearing pain [ Time Frame: 1,6 weeks after the last injection ]
    using 100mm-VAS

  • WOMAC-likert assessment [ Time Frame: 1,6,12 weeks after the last injection ]
    Pain, Function, Stiffness, Total score

  • Patient Global Assessment [ Time Frame: 1,6,12 weeks after the last injection ]
    using 100mm-VAS

  • Investigator Global Assessment [ Time Frame: 1,6,12 weeks after the last injection ]
    using 100mm-VAS


Enrollment: 287
Study Start Date: December 2011
Study Completion Date: October 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo and then LBSA0103
The experimental group receive once weekly for 2 weeks intraarticular injections of Placebo(saline). And then, they receive once intraarticular injections of LBSA0103 into the target knee.
Drug: Placebo
First 2 weeks Placebo(2ml) once weekly in experimental group
Drug: LBSA0103
at third week LBSA0103(60mg) once in experimental group
Active Comparator: Hyruan Plus
The control group received once weekly for 3 weeks intraarticular injections of Hyruan Plus Inj. into the target knee.
Drug: Hyruan Plus
Hyruan Plus Inj. (2ml)once weekly for 3 weeks in control group

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 40 years of age
  • Kellgren & Lawrence grade I-III
  • If there is more than one knee having a weight bearing pain of at least 40mm evaluated by 100mm VAS
  • Be willing to discontinue all nonsteroidal anti-inflammatory drugs(NSAIDs), analgesics, condroichin sulfate/glucosamine or physical therapy for the duration of the study

Exclusion Criteria:

  • Body mass index > 32
  • Have rheumarthritis
  • Patients who have a weight-bearing pain of less than 40mm on both knees when measured by 100mm-VAS
  • Have Sudek's atrophy, Paget's disease, Spinal disc herniation
  • Kellgren & Lawrence Grade IV
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01510535


Locations
Korea, Republic of
Seoul National University Hospital
Jongno-gu, Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
  More Information

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01510535     History of Changes
Other Study ID Numbers: LG-HACL010
First Submitted: January 6, 2012
First Posted: January 16, 2012
Last Update Posted: January 17, 2013
Last Verified: January 2013

Keywords provided by LG Life Sciences:
Osteoartritis
Knee
LBSA0103
Hyruan Plus Inj.

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases